scholarly journals Efficacy of Chinese herbal medicine Jiangniaosuan formula for treatment of hyperuricemia: study protocol for a double-blinded non-inferiority randomized controlled clinical trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Yafang Guo ◽  
Hong Lu ◽  
Jing Gan ◽  
Dongdong Li ◽  
Jiandong Gao ◽  
...  

Abstract Background Jiangniaosuan formula (JNSF) is commonly used in China for treating hyperuricemia, but there is little research-based evidence to support its use. This randomized controlled trial aims to assess the efficacy and safety of JNSF. Methods A total of 72 patients with hyperuricemia will be selected and randomly assigned in a ratio of 1:2 to receive either Western medicine, i.e., febuxostat 40 mg (WG group; n = 24), or Chinese herbal medicine, i.e., Jiangniaosuan formula + febuxostat 20 mg (WJNSG group; n = 48). After 12 weeks, the WJNSG will be randomly divided into two groups of 24 patients each; one group (WJNSG; n = 24) still will receive febuxostat 20 mg + Jiangniaosuan formula, and the other group (JNSG; n = 24) will continue to receive Jiangniaosuan formula + placebo. Participants will be followed up at 4-week intervals. The primary outcome will be the change in serum uric acid level, and the secondary outcome will be the change in traditional Chinese medicine (TCM) syndrome scores. Serum creatinine, blood glucose, and insulin levels will also be measured. Discussion We hypothesize that patients with hyperuricemia will benefit from JNSF. This study will provide evidence-based recommendations for clinicians. Dissemination The results will be published in a peer-reviewed journal and disseminated by academic conferences. The datasets analyzed during the current study are available from the corresponding author on reasonable request. Trial registration Chinese Clinical Trials Register ChiCTR2000041083. Registered on 3 May 2021. The protocol version number is V3.0, 20210301.

2021 ◽  
Author(s):  
Yafang Guo ◽  
Hong Lu ◽  
Jing Gan ◽  
Dongdong Li ◽  
Jiandong Gao ◽  
...  

Abstract Background: Jiangniaosuan formula (JNSF) is commonly used in China for treating hyperuricemia, but there is little research-based evidence to support its use. This randomized controlled trial aims to assess the efficacy and safety of JNSF.Methods: A total of 72 patients with hyperuricemia will be selected and randomly assigned in a ratio of 1:2 to receive either Western medicine i.e., febuxostat 40 mg (WG group; n = 24) or Chinese herbal medicine group, i.e., Jiangniaosuan formula + febuxostat 20 mg (WJNSG; n = 48). After 12 weeks, the WJNSG will be randomly divided into two groups of 24 patients each; one group (WJNSG; n = 24)still will receive febuxostat 20 mg + Jiangniaosuan formula and the other group(JNSG; n = 24) will continue to receive Jiangniaosuan formula+Placebo. Participants will be followed up at 4-week intervals. The primary outcome will be the change in serum uric acid level, and the secondary outcome will be the change in Traditional Chinese Medicine (TCM) syndrome scores. Serum creatinine, blood glucose, and insulin levels will also be measured.Discussion: We hypothesize that patients with hyperuricemia will benefit from JNSF. This study will provide evidence-based recommendations for clinicians.Dissemination: The results will be published in a peer-reviewed journal and disseminated by academic conferences.Trial registration : This trial is registered with ClinicalTrials.gov, number ChiCTR2000041083. 22 Registered on 3 May 2021.


NUCLEUS ◽  
2020 ◽  
Vol 1 (2) ◽  
pp. 85-94
Author(s):  
Sidik Maulana ◽  
Maria Komariah ◽  
Siti Nurjanah

Pemanfaatan pengobatan herbal (herbal medicine) telah banyak dipraktikkan secara luas dalam berbagai pengobatan mulai dari gejala sampai dengan penyakit kronis. meta-analisis yang dilakukan pada tahun 2015 terhadap chinese herbal medicine untuk gangguan tidur melaporkan tidak menemukan perbedaan yang signifikan dengan plasebo yang digunakan, namun update studi dengan desain RCT menunjukkan efektivitas. sehingga peneliti melakukan update review mengenai efektivitas pengobatan herbal untuk gangguan tidur. Desain penelitian ini adalah literature review dengan pendekatan deskriptif kualitatif. metode analisis menggunakan pendekatan tematik analisis. pencarian artikel menggunakan kata kunci: (((herbal medicine) OR (chinese medical herbal) AND (y_10[Filter])) AND ((sleep disorder) OR (insomnia) AND (y_10[Filter]))) AND (sleep quality AND (y_10[Filter])) dengan kriteria inklusi tahun terbit 2010-2020 menggunakan desain penelitian randomized controlled trial berbahasa Inggris dan Indonesia. Update literatur terkait pengobatan herbal untuk gangguan tidur menunjukkan berbagai pengobatan herbal efektif untuk gangguan tidur karena memiliki kandungan sedatif-hipnotik sehingga meningkatkan rasa tenang. frekuensi pengobatan mulai dari 20 minggu sampai dengan 28 hari. Update pengobatan herbal terbukti efektif untuk mengatasi gangguan tidur. Studi ini masih terbatas pada pengguna satu database sehingga memiliki bias yang tinggi dalam pengambilan simpulan.


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